Brentuximab vedotin

Brentuximab vedotin (Adcetris, Takeda Pharma A/S) has 7 EU-approved indications in 2 tumour types. 5 need a biomarker result: CD30 (5).
Approved indications of Brentuximab vedotin
Biomarker requirementRegimenSettingConditions
Hodgkin lymphoma4
CD30 CD30+
+ doxorubicin, vinblastine and dacarbazine
1L
advanced
None
CD30 CD30+
+ etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone
1L
advanced
Stage IIB with risk factors, Stage III or Stage IV
CD30 CD30+
Monotherapy
Consol.
Following autologous stem cell transplant (ASCT); At increased risk of relapse or progression
CD30 CD30+
Monotherapy
3L+
Following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option
T-cell lymphoma3
None
+ cyclophosphamide, doxorubicin and prednisone
1L
Systemic ALCL only
None
Monotherapy
2L
Systemic ALCL only; Relapsed or refractory disease
CD30 CD30+
Monotherapy
2L
Cutaneous T-cell lymphoma only; After at least 1 prior systemic therapy
Full text of section 4.1 (therapeutic indications)

Hodgkin lymphoma ADCETRIS is indicated for adult patients with previously untreated CD30+ Stage III or IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD) (see sections 4.2 and 5.1). ADCETRIS is indicated for adult patients with previously untreated CD30+ Stage IIB with risk factors, Stage III or Stage IV HL in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone (BrECADD) (see sections 4.2 and 5.1). ADCETRIS is indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following autologous stem cell transplant (ASCT) (see section 5.1). ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL): 1. following ASCT, or 2. following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option. Systemic anaplastic large cell lymphoma ADCETRIS in combination with cyclophosphamide, doxorubicin and prednisone (CHP) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) (see section 5.1). ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory sALCL. Cutaneous T-cell lymphoma ADCETRIS is indicated for the treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy (see section 5.1).

Label history

49 changes to the Adcetris label since 2013, 6 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes